Breast CancerPhase 2SASHANCT07654257
Single FrAction Interstitial BreaSt BracHytherApy
A Phase 2 study testing Partial Breast Irradiation in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Partial Breast Irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to 31 Oct 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
- Age 40-85 at diagnosis
- Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
- T stage of Tis, T1, or T2
- T2 tumors must be ≤3 cm in maximum diameter
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- If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy
- For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection [with a minimum of 6 axillary nodes removed]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion
- Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
- ≥70 years of age
- Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2-
- Grade 1-2 breast cancer
- Tumor ≤2 cm in size
- Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:
- 50-69 years of age
- Grade 1-2 breast cancer
- Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI)
- ER+, PR+, HER2-
- Tumor ≤2 cm in size
- Agrees to comply with aromatase inhibitor recommendation
- Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Pregnant or breastfeeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
- Any prior history of breast radiation therapy (RT) or thoracic RT for any condition
- Multicentric carcinoma (DCIS or invasive)
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- Synchronous bilateral invasive or non-invasive breast cancer
- Surgical margins that cannot be microscopically assessed or that are positive
- Treatment with neoadjuvant chemotherapy
- Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO Breast Team, 804-828-5406, masseyctbrst@vcu.edu
Bridget Quinn, MD
About this study
Official title: Single FrAction Interstitial BreaSt BracHytherApy (SASHA)
This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
- Conditions
- Breast Cancer
- Being tested
- Partial Breast Irradiation
- Keywords
- Breast Cancer, Radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Breast IrradiationDrug
Also called Brachytherapy
16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
| Study group | Role | What they receive |
|---|---|---|
| Partial Breast Irradiation | Experimental | Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day Receives: Drug: Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205)
Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting.
Measured: Baseline through 30 days following treatment, up to 5 years.
Secondary outcomes (6)
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12)
Cosmetic results at 1, 3, and 5 years after APBI, as assessed by The Breast Cancer Treatment Outcome Scale (BCTOS-12), a shortened, validated patient-reported outcome measure designed to assess aesthetic and functional outcomes after breast-conserving surgery. This is scored on a scale of 1-4 ("no difference" to "large difference"), where lower scores indicate better outcomes of satisfaction
Measured: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q)
The BREAST-Q radiation-specific module patient-reported outcome measure (PROM) that evaluates patient satisfaction with the cosmetic effects of radiation The Breast-Q is 6 questions and scored on a scale of 1-3 ("not at all" to "a lot") with lower scores indicating better outcomes of satisfaction.
Measured: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
The Harvard Cosmesis Scale is a physician-rated form will be used by the radiation oncologist to score cosmesis with the following criteria:
- Excellent: treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring.
- Good: minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring.
- Fair: significant radiation effects readily observable.
- Poor: severe sequelae of breast tissue secondary to radiation effect.
Measured: Baseline, 6 months, then annually up to 5 years following treatment
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs
Digital photographs will be taken to visualize any potential changes in breast shape or contour. These will be taken by study staff utilizing the Radiation Oncology Department's designated camera. blindly analyzed by 2-3 radiation oncologists using the following 4-point numerical scale:
- 4 (Excellent): the treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring.
- 3 (Good): minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring.
- 2 (Fair): significant radiation effects readily observable.
- 1 (Poor): severe sequelae of breast tissue secondary to radiation effect. Photos will be uploaded to the digital study record.
Analysis will be batched as study progresses. Each individual score as well as the average score will be entered into the electronic case report form (eCRF).
Measured: Baseline, 5 weeks, 6 months, annually up to 5 years following treatment
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)
Incidence of treatment-related breast toxicities of interest occurring at any grade within 5 years after APBI. Toxicities will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.
Measured: Baseline, up to 5 years following treatment
Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI
Disease control will be assessed by physical examination and mammography. All cases of local failure must be confirmed using pathologic criteria established by Recht et al will be used to help classify the type of local in-breast recurrence as follows:
- True Recurrence/Marginal Miss (TR/MM) Failure: a recurrence of the treated cancer within or immediately adjacent to the primary tumor site.
- Elsewhere (E) Failure: local recurrence several centimeters from the primary site and is generally believed to be a new primary cancer.
Classification of the failure type is at the discretion of the treating investigator.
Measured: 1 year, 3 years, and up to 5 years following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start19 Oct 2026
- Primary completion31 Oct 2036 (estimated)
- Study completion31 Oct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridget Quinn, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654257
- Sponsor's protocol ID
- MCC-25-22764
- Other IDs
- HM300001026
- Acronym
- SASHA
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single FrAction Interstitial BreaSt BracHytherApy (SASHA)
- ClinicalTrials.gov ID
- NCT07654257
- Acronym / sponsor ID
- SASHA / MCC-25-22764
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 31 Oct 2036 (estimated)
- Study completion
- 31 Oct 2036 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| Partial Breast Irradiation | Experimental | Drug: Partial Breast IrradiationBrachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female
- New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
- Age 40-85 at diagnosis
- Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
- T stage of Tis, T1, or T2
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
- Any prior history of breast radiation therapy (RT) or thoracic RT for any condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Breast IrradiationAlso: Brachytherapy16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day | Drug | Partial Breast Irradiation |
Primary outcome
Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205)
Time frame: Baseline through 30 days following treatment, up to 5 years.
Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting.
6 secondary outcomes
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12)
Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q)
Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment
Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale
Time frame: Baseline, 6 months, then annually up to 5 years following treatment
Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs
Time frame: Baseline, 5 weeks, 6 months, annually up to 5 years following treatment
Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI)
Time frame: Baseline, up to 5 years following treatment
Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI
Time frame: 1 year, 3 years, and up to 5 years following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bridget Quinn, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partial Breast Irradiation in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) (time frame: Baseline through 30 days following treatment, up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.